SKYRIZI: An IL-23/p19 inhibitor2-7
LIMMitless
DURABLE, COMPLETE CLEARANCE
with no loss of response as assessed by PASI 10021
From an ongoing open-label extension, single-arm study (integrated UltIMMa-1/2, IMMvent, SustaIMM, and NCT03255382)
Consistent PASI 100 rates through ~5.5 years (52-304 weeks) (OC)21
| * | SKYRIZI dosing: Participants received 150 mg (two 75-mg subcutaneous injections) SKYRIZI at Week 0, Week 4, and every 12 weeks thereafter. |
| Patients achieving PASI 100: Integrated UltIMMa-1/2, IMMvent, SustaIMM, and NCT03255382 continuous SKYRIZI treatment data Week 0 to Week 304 (OC analysis).21 | |
| † | Observed cases. No imputation of missing data; patients missing data at a visit were excluded from the observed analysis for that visit. |
| ‡ | 637 of the 671 ongoing patients completed the assesment visit at Week 304; 59 ongoing patients had reached the assessment window but had not yet completed the assessment visit at Week 304.21 |
In LIMMitless, an open-label extension with integrated results from UltIMMa-1 and UltIMMa-2 (LOCF)22,23*
8 OUT OF 10 PATIENTS WHO SWITCHED FROM USTEKINUMAB TO SKYRIZI ACHIEVED PASI 90 AT WEEK 13622,23
MORE THAN HALF OF PATIENTS WHO SWITCHED FROM USTEKINUMAB TO SKYRIZI ACHIEVED PASI 100 AT WEEK 13622,23
| SKYRIZI doses denoted in blue: Participants received 150 mg (two 75-mg subcutaneous injections) at Week 0, Week 4, and every 12 weeks thereafter. Ustekinumab 45 mg or 90 mg (weight-based per label). Ustekinumab is dosed every 12 weeks after 2 starter doses at Week 0 and Week 4. | |
| Key variables measured every 12 weeks through OLE: sPGA 0/1, sPGA 0, PASI 75, PASI 90, and PASI 100.8,21 | |
| * | Missing data were imputed using last observation carried forward (LOCF) upon entry to UltIMMa-1 or UltIMMa-2. |
| † | The RCT data shown here are integrated results from UltIMMa-1 and -2. The OLE data are a sub-analysis of LIMMitless and include only patients from UltIMMa-1 and -2 who completed the RCT and enrolled in the OLE. |
| Limitations: In an OLE, there is potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out. |
Sub-analysis contextual information22,23
The RCT data shown are from a post hoc integrated analysis of the UltIMMa-1 and UltIMMa-2 replicate Phase 3, randomized, double-blinded, placebo- and active comparator–controlled studies comparing SKYRIZI and ustekinumab efficacy and safety with long-term SKYRIZI data analysis from the LIMMitless ongoing, Phase 3, single-arm, international, multicenter OLE study. This data only includes patients from UltIMMa-1 and UltIMMa-2 who completed the RCT and then enrolled in the OLE. Following completion of the RCT period, patients on blinded ustekinumab were switched to open-label SKYRIZI.
LIMMitless OLE21
LIMMitless is an ongoing, Phase 3, single-arm, multicenter, international OLE study evaluating the long-term efficacy and safety of SKYRIZI (150 mg) in adult patients with moderate to severe plaque psoriasis who have participated in multiple Phase 2/3 studies. All patients in LIMMitless received SKYRIZI 150 mg every 12 weeks for the duration of their participation in the study. Key variables measured every 12 weeks through OLE were sPGA 0/1, sPGA 0, PASI 75, PASI 90, and PASI 100.
Patients were initially randomized to receive SKYRIZI 150 mg in 1 of 5 base Phase 2/3 studies:
- UltIMMa-1
- UltIMMa-2
- SustaIMM
- IMMvent
- NCT03255382
897 of 955 patients who completed one of the 5 base studies entered the LIMMitless OLE study and continued to receive SKYRIZI 150 mg every 12 weeks. Following completion of the RCT period, patients on blinded ustekinumab were switched to open-label SKYRIZI.
Limitations: In an OLE, there is potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.
Dosing: SKYRIZI 150 mg (two 75-mg subcutaneous injections) at Week 0, Week 4, and every 12 weeks thereafter. Ustekinumab 45 mg or 90 mg (weight-based per label). Ustekinumab is dosed every 12 weeks after 2 starter doses at Week 0 and Week 4.
|
100% IMPROVED OR OR MAINTAINED PASI RESPONSE AT WEEK 84 AFTER SWITCHING FROM USTEKINUMAB TO SKYRIZI (LOCF)25‡
| ‡ | Improved or maintained response (n=53/53) was defined as a patient who was PASI ≥75 to <90 and either improved to a PASI 90 response or maintained by remaining categorized as PASI ≥75 to <90. |
Subgroup analysis25
| The subgroup was composed of patients with a PASI score ≥75 to <90 at Week 52 in the randomized, controlled trial (RCT) while taking ustekinumab, who were then switched to SKYRIZI at the entry of the OLE (n=53/172). Following completion of the RCT period, patients on blinded ustekinumab were switched to open-label SKYRIZI. Starting at Week 52, switching patients received SKYRIZI 150 mg every 12 weeks. |
| Subgroup analysis limitations: This analysis is post hoc, does not assess a prespecified endpoint, was not adjusted for multiplicity, comprises a small sample size, and the assessed outcomes are dichotomous (yes/no for PASI response cutoffs). Therefore, treatment differences cannot be regarded asstatistically significant. |
| OLE limitations: In an OLE, there is a potential for enrichment of the long-term data in the remaining populations since patients who are unable to tolerate or do not respond to thedrug often drop out. |
Study design22,23,25 |
LIMMitless OLE21
LIMMitless is an ongoing, Phase 3, single-arm, multicenter, international, open-label extension (OLE) study evaluating the efficacy and safety of SKYRIZI (150 mg) in adult patients with moderate to severe plaque psoriasis.
All patients in LIMMitless received SKYRIZI 150 mg every 12 weeks for the duration of their participation in the study.
Patients were initially randomized to receive SKYRIZI 150 mg in 1 of 5 base Phase 2/3 studies:
• UltIMMa-1
• UltIMMa-2
• SustaIMM
• IMMvent
• NCT03255382
897 of 955 patients who completed one of the 5 base studies entered the LIMMitless OLE study and continued to receive SKYRIZI 150 mg every 12 weeks.
OLE limitations: In an open-label extension, there is a potential for enrichment of the long-term data in the remaining populations. Patients who are unable to tolerate or do not respond to the drug often drop out.
Observed cases (OC): No imputation of missing data; patients missing data at a visit were excluded from the observed analysis for that visit.
Dosing: SKYRIZI 150 mg (two 75-mg subcutaneous injections) at Week 0, Week 4, and every 12 weeks thereafter.
Watch time: 8 min.
See Dr. Chi-ho Hong discuss his experience with the LIMMitless OLE
Posted 10/28/22
UltIMMa-1 and UltIMMa-2 replicate Phase 3 PsO study designs1,8
PASI 90 and PASI 100 clearance of psoriatic lesions at Week 52 vs ustekinumab were ranked secondary endpoints.
Data analysis: Missing data were imputed as nonresponders (NRI) for categorical endpoints and by last observation carried forward for continuous endpoints.
Co-primary endpoints: Proportion of patients who achieved PASI 90 response and an sPGA score of clear or almost clear (sPGA 0 or 1) at Week 16 vs placebo.
Ranked secondary endpoints: All 15 secondary ranked endpoints vs placebo and/or ustekinumab at Week 16 and/or Week 52 were met in both UltIMMa-1 and UltIMMa-2 (P<0.0001).
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